Status:
NOT_YET_RECRUITING
Aspirin 150 mg vs 100 mg for Prevention of Preeclampsia in High-Risk Obese Pregnant Women
Lead Sponsor:
FANG HE
Conditions:
Preeclampsia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
According to the American College of Obstetricians and Gynecologists (ACOG), pregnancy-induced hypertension is defined as a new onset of systolic and/or diastolic blood pressure ≥140/90 mmHg after 20 ...
Detailed Description
This study aims to compare the efficacy and safety of 100 mg and 150 mg aspirin in preventing preeclampsia in obese pregnant women and to optimize the LDA strategy for the prevention of preeclampsia. ...
Eligibility Criteria
Inclusion
- Age 18-45 years;
- Pregnancy 12-16 weeks, NT normal;
- Singleton pregnancy;
- a.BMI ≥35kg/m²; b. 28≤BMI \<35 kg/m², and at least one risk factor: history of preeclampsia, chronic hypertension, type 1 or type 2 diabetes, autoimmune disease (excluding antiphospholipid syndrome), nulliparous, family history of preeclampsia, placental abruption, stillbirth, SGA, more than 10 years between pregnancies, in vitro fertilization-embryo transfer;
- Sign informed consent
Exclusion
- 1\. Aspirin allergy or contraindication (such as active gastric ulcer, coagulation disorder); 2. Multiple pregnancies; 3. Other severe comorbidities that may lead to pregnancy complications; 4. Seizures; 5. Renal disease, baseline proteinuria (proteinuria\> 3+, or protein-to-creatinine ratio ≥ 0.3); 6. Patients taking aspirin for other reasons (such as stroke, heart disease)
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 6 2028
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT06952712
Start Date
May 7 2025
End Date
May 6 2028
Last Update
May 8 2025
Active Locations (1)
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1
Fang He
Guangzhou, Guangdong, China, 510150